CLARENCE, N.Y. (WIVB) — 22nd Century Group is trying to become the world’s first manufacturer of cigarettes with the distinction “very low nicotine.”

And while it could be another year before the FDA issues an approval on their request, experts say this could be another important tool in what many people say is the hardest thing they’ve ever done: quitting smoking.

“Nicotine is a powerful, a very powerful, addicting agent,” said Andrew Hyland, chairman of the department of health behavior at Roswell Park Cancer Institute, who’s done limited research on very low nicotine products.

But what if the millions of smokers across New York who fail at quitting every year can turn to what some consider the future of the industry? They’re called very low nicotine cigarettes, and the company that’s behind the technology is located in Clarence.

“Unlike conventional cigarettes, which are very high in nicotine, ours are a reduced tobacco-based product,” said Gregg Gellman, director of business development and regulatory affairs for the 22nd Century Group.

22nd Century has secured 200 patents to create the only genetically modified form of tobacco in the world that has the very low nicotine distinction.The product is currently sold in Spain. It could be sold domestically, but without the “very low nicotine” label, Gellman said.

“The paradigm shift is to commercialize and develop less or reduced tobacco-based products,” Gellman said. “In short, every other option that’s been implemented, has failed. Absent of introducing anything that is more harmful than what you as the smoker are currently engaged in, it is the paradigm shift that we see.”

That means people who use their product will still be smoking, but they’ll be ingesting just a fraction of the nicotine as traditional cigarettes. That’s key, experts say.

“The primary thing that makes it so difficult to quit is dependence on nicotine,” Hyland said.

New Yorkers make up 2.1 million of the 44 million Americans who smoke. Of those, two-thirds will fail at trying to quit every year. Hyland says anything that can help people kick the habit is a step that could save their life.

“It’s the nicotine that keeps you coming back to those products,” Hyland said. “For someone who’s able to use a product, like a very low nicotine product, or any product for finite period of time and switch completely off the Marlboros and Camels, that’s a success story in my book.”

While Hyland said the jury is still out on the overall success of cessation products alone, something is better than nothing. But he said smokers are too often tempted by nicotine, and revert to old habits or relapse.

“The big caveat is, when you go to the store and there’s the low nicotine cigarettes and the regular Marlboros, compliance with adhering to that treatment is pretty low,” Hyland said.
The New England Journal of Medicine featured a six-week study that showed progress in helping people to smoke less. The study was funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products, according to the Journal’s website.

According to the study: “(R)educed-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked.”

The application submitted to the FDA by 22nd Century is specifically requesting the use of a label on their cigarette box that would read “very low nicotine.” Gellman said if approved, it would be the only one of its kind on the public or prescription market.

Meetings between the FDA and 22nd Century take place early this year. Gellman said the company will be working toward FDA approval by the end of 2016. Products could hit the shelves by early 2017.

“It is our hope, that because that this is such an intrinsic health concern that we will be able to get this approved in a swift and fast process,” Gellman said.

The company has also committed to staying in Buffalo, Gellman said. While manufacturing facilities are in North Carolina — little tough to grow tobacco in western New York — its headquarters is located off Main Street.

Gellman said the company has seen rapid growth since moving to Clarence. In 2014, profits were approximately $500,000. They grew to nearly $8 million last year, and are projected to jump to $12 million in 2016.